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Rivastigmine 10 cm^2 transdermal patch
Rivastigmine 10 cm^2 transdermal patch is a Cholinesterase inhibitor Small molecule drug developed by Novartis. It is currently in Phase 3 development for Alzheimer's disease, Parkinson's disease dementia.
Rivastigmine is a cholinesterase inhibitor that works by increasing the concentration of acetylcholine in the brain, which helps to improve cognitive function in patients with Alzheimer's disease.
Rivastigmine is used to treat Alzheimer's Disease, as indicated by ClinicalTrials.gov. The drug is available in a transdermal patch form, including a 10 cm^2 patch, which delivers the medication through the skin.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Rivastigmine 10 cm^2 transdermal patch |
|---|---|
| Sponsor | Novartis |
| Drug class | Cholinesterase inhibitor |
| Target | Acetylcholinesterase |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the enzyme acetylcholinesterase, rivastigmine prevents the breakdown of acetylcholine, a neurotransmitter involved in memory and learning. This leads to an increase in acetylcholine levels in the brain, which can help to improve cognitive symptoms in patients with Alzheimer's disease.
Approved indications
- Alzheimer's disease
- Parkinson's disease dementia
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Fatigue
- Headache
Key clinical trials
- Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease (PHASE3)
- Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease (PHASE3)
- Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44 (PHASE4)
- Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline (PHASE3)
- Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD) (PHASE3)
- A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rivastigmine 10 cm^2 transdermal patch CI brief — competitive landscape report
- Rivastigmine 10 cm^2 transdermal patch updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Rivastigmine 10 cm^2 transdermal patch
What is Rivastigmine 10 cm^2 transdermal patch?
How does Rivastigmine 10 cm^2 transdermal patch work?
What is Rivastigmine 10 cm^2 transdermal patch used for?
Who makes Rivastigmine 10 cm^2 transdermal patch?
What drug class is Rivastigmine 10 cm^2 transdermal patch in?
What development phase is Rivastigmine 10 cm^2 transdermal patch in?
What are the side effects of Rivastigmine 10 cm^2 transdermal patch?
What does Rivastigmine 10 cm^2 transdermal patch target?
Related
- Drug class: All Cholinesterase inhibitor drugs
- Target: All drugs targeting Acetylcholinesterase
- Manufacturer: Novartis — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Alzheimer's disease
- Indication: Drugs for Parkinson's disease dementia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing